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iScan Optical Coherence Tomography System - Indonesia BPOM Medical Device Registration

iScan Optical Coherence Tomography System is a medical device registered with Indonesia's BPOM (Badan Pengawas Obat dan Makanan) under Analysis ID AKL 21201916079. The device is manufactured by OPTOVUE, INC from United States, and is classified as Risk Class Kelas Resiko : B. The authorized representative in Indonesia is SURYA TAMA MEDIKA.

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BPOM Registered
Risk Class Kelas Resiko : B
iScan Optical Coherence Tomography System
Analysis ID: AKL 21201916079

Risk Classification

Kelas Resiko : B

Product Class

Kelas : 2

Manufacturer

OPTOVUE, INC

Country of Origin

United States

Authorized Representative

SURYA TAMA MEDIKA

AR Address

Jl m hasibuan ruko suncity pbb. 37 real blok e.27 rt 004 rw 002 kel margajaya kec bekasi selatan kota bekasi

Registration Date

Jul 29, 2024

Expiry Date

Feb 27, 2026

Product Type

Diagnostic Eye Equipment

Optical Coherence Tomography

Non Radiation Electromedics

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